Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT07120750
Eligibility Criteria:
Inclusion Criteria:
* Age: Participants must be between 18 and 70 years of age.
* HBsAg Positive: Participants must be positive for hepatitis B surface antigen (HBsAg).
* Confirmed Hepatocellular Carcinoma (HCC): Participants must have a pathological confirmation of HCC via surgical resection or local ablation.
* BCLC Staging: Participants must have a Barcelona Clinic Liver Cancer (BCLC) staging of 0 or A.
* Liver Function: Participants must have normal or well-compensated liver function, classified as Child-Pugh A.
* Expected Survival: Participants must have an expected survival of more than 3 months.
* Informed Consent: Participants must sign an informed consent form and agree to comply with the study requirements. If a participant is unable to sign the consent form, a legal guardian or agent must do so.
Exclusion Criteria:
* Prior Systemic Cancer Treatments: Participants who have received prior systemic cancer treatments such as liver transplantation, chemotherapy, targeted therapy, or biological therapy will be excluded.
* Other Active Malignancies: Participants with a history or presence of other active malignancies, except for skin basal cell carcinoma or squamous cell carcinoma that has been cured, or cervical carcinoma in situ, will be excluded.
* Allergies to Interferon: Participants who are allergic to interferon or any of its components, or whom the investigator deems unsuitable for interferon therapy, will be excluded.
* Other Chronic Liver Diseases: Participants with other chronic liver diseases such as hepatitis A, C, D, or E virus infection, alcoholic liver disease, genetic metabolic liver disease, or drug-induced liver disease will be excluded.
* Autoimmune Diseases:Participants with autoimmune diseases,including autoimmune liver disease and psoriasis, will be excluded.
* Severe Liver Dysfunction: Participants with severe liver dysfunction or decompensated cirrhosis will be excluded.
* Renal Impairment: Participants with serum creatinine levels exceeding 1.5 times the upper limit of normal will be excluded.
* Severe Systemic Diseases:Participants with severe systemic diseases affecting the heart,lungs,kidneys,brain,or blood will be excluded.
* Severe Neuropsychiatric Disorders:Participants with severe neuropsychiatric disorders such as epilepsy, depression, mania, or schizophrenia will be excluded.
* Unstable Medical Conditions:Participants with unstable diabetes,hypertension,hyperthyroidism,or other endocrine diseases will be excluded.
* Retinopathy:Participants with a history of severe retinopathy or other evidence of retinopathy will be excluded.
* Substance Abuse:Participants with a history of drug abuse or alcoholism will be excluded.
* Pregnancy or Breastfeeding:Pregnant or breastfeeding women, or women planning to become pregnant during the study period who are unwilling to use contraception, will be excluded.
* Investigator's Judgment:Participants whom the investigator deems unsuitable for the study based on their current medical condition will be excluded.
* Concurrent Participation in Other Trials:Participants who are concurrently involved in other clinical research trials will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07120750
Study Brief:
Protocol Section:
NCT07120750